The National Institute of Diabetes and Digestive and
Kidney Diseases (NIDDK) invites applications for Planning Centers for
Interdisciplinary Research in Benign Urology (IR-BU) (P20). The intent of
this solicitation is to encourage studies that take an integrative approach
towards addressing problems in benign urology. Because lower urinary tract
symptoms, such as frequency, urgency, dysuria, terminal dribbling etc., are
descriptive, it has been difficult to attribute these symptoms to specific
etiologies or to particular urinary tract organs and tissues, supporting
structures, or to the peripheral or central nervous system. Furthermore, the
lack of fundamental information about lower urinary tract development and
physiology has hampered the ability to develop strategies to address lower
urinary tract symptoms. These planning centers are to foster programs that
undertake a broad approach towards research in benign urology that can
integrate investigations of organ-specific development and genetics,
structure and function, and physiology and pathophysiology with in vivo
studies to understand the potential interplay of urologic and non-urologic
organs and tissues. The research teams are expected to be built from
established investigators from the basic science and urology and other
disciplines. Each IR-BU Center (P20) is limited to a single Scientific
Project and must contain an Administrative Core and an Educational Enrichment
Program.

Key Dates

Posted Date

December 21, 2011

Letter of Intent Due Date

February 20, 2012

Application Due Date(s)

March 20, 2012

AIDS Application Due Date(s)

Not Applicable.

Scientific Merit Review

June-July 2012

Advisory Council Review

October 2012l

Earliest Start Date(s)

December 2012

Expiration Date

March 21, 2012

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in
the PHS398
Application Guide except where instructed to do otherwise (in this FOA or
in a Notice from the NIH Guide
for Grants and Contracts). Conformance to all requirements (both in
the Application Guide and the FOA) is required and strictly enforced. While
some links are provided, applicants must read and follow all application
instructions in the Application Guide as well as any program-specific
instructions noted in Section IV. When
the program-specific instructions deviate from those in the Application Guide,
follow the program-specific instructions. Applications that do not
comply with these instructions may be delayed or not accepted for review.

The impact and burden of lower urinary tract symptoms to
patients are enormous. Patients suffer considerable morbidity throughout their
lives, leading to a decreased quality of life for the patient and their
families. Epidemiological data suggest the prevalence of lower urinary tract
symptoms, LUTS/BPH, UI, and OAB is high, but measured prevalence varies
substantially due to a lack of uniform definitions and the methods of
collection. For example, the prevalence of UI appears to vary from 2.5% to 60%,
depending on the population. Despite this variation, UI is the leading cause
for admission to nursing homes. Management of UI is dependent upon surgery
(which is only partially effective) or a single class of approved drugs. This
class of drugs is only 13-25% more effective than placebo and 2/3 of patients
discontinue use because of side effects. LUTS/BPH and OAB are treated with a
wide variety of costly drug, surgical, and behavioral treatments that are only
aimed at alleviating the symptoms, even though diverse causes are likely to
underlie both syndromes. Neurogenic bladder is treated by surgical or other
invasive procedures that ultimately do not address the underlying etiology.

The consequences of many congenital urinary malformations may
lead to lower urinary tract symptoms. Thus, advancements in our knowledge of
the developmental processes underlying lower urinary tract structure and
function, as well as further understanding of the physiological changes
associated with urinary tract symptoms will also enhance our ability to develop
improved treatment for the consequences of urinary tract malformation.
Vesicoureteral reflux (VUR) is such a developmental defect and affects up to
10% of newborns (approximately 450,000 babies) every year. VUR results from the
abnormal attachment of the ureter to the bladder that causes retrograde flow of
urine into the ureter and kidney. Depending upon the severity, VUR will resolve
spontaneously or can lead to renal failure. A severe complication of VUR is
urinary tract infection that can lead to renal damage or scarring. Current
treatment of VUR is moderately successful and ranges from antibiotic
prophylaxis and regular radiographic evaluation to surgical procedures.
Establishing effective prevention and management of lower urinary tract
symptoms and congenital urinary malformation will require an understanding of
the underlying causes and the normal and abnormal development of the organ
systems involved.

The strategy of the IR-BU program is to foster teams capable
of undertaking studies to identify the root causes and systems involved in
lower urinary tract symptoms. As such, active team members are expected to
represent a broad field of expertise capable of leading studies that will promote
an understanding of the normal development, maturation, and physiology of organ
systems likely to be involved, and the study of the pathophysiology of animal
models that mimic aspects of lower urinary tract symptoms. The development of
conceptual and mechanistic models and in vivo animal experimental systems that
recapitulate specific lower urinary tract symptoms is crucial for understanding
and testing the complex interplay of urologic and non-urologic organs. This
approach and the closer examination of relevant patient populations will
provide a basis for developing testable conceptual and mechanistic models. To
date discipline-focused, research teams have not undertaken such approaches.

Knowledge gained from these studies will serve as the
foundation to develop effective treatments and strategies for prevention. In
addition, characterization of in vivo animal models that mimic aspects of
specific lower urinary tract symptoms will help direct the improved detailed
phenotyping of patients and thereby support the development of more informative
patient subgroups. Stratification of patient populations should provide a means
to select optimal prevention and therapeutic strategies to improve the clinical
outcomes for patients with lower urinary tract symptoms.

Overall
structure and goals

Each IR-BU Center will consist of a team coalesced around a
single scientific topic and scientific project. Because the goal of the IR-BU
program is to foster new teams, applications will not require preliminary data
to establish the collaborative interactions of the team members, but rather one
of th goals of the Center is to generate the preliminary data necessary to
establish the bona fides of the IR-BU participants as a well-integrated
interdisciplinary research team. The IR-BU Centers are expected within a
two-year period to develop well-designed interdisciplinary projects suitable
for submission for a George M. O’Brien Urology Research Center (P50), a multi-PD(s)/PI(s)
R01, or a Program Project (P01) award. However, IR-BU Centers can be considered
for renewal. Each center will have an Administrative Core which is responsible
for 1) the allocation and oversight of all IR-BU Center resources, 2)
establishing and maintaining all collaborations and the Educational Enrichment
program, and 3) working with the local regulatory bodies to ensure that human
subject or vertebrate animal research is in compliance with appropriate
regulations and guidelines governing animal use and studies involving human
subjects research.

Center
Director

The Center Director must be an established investigator and
will be responsible for scientific and administrative leadership. This
includes, but is not limited to, the following duties:

Maintaining the Center’s vision and ensuring the relevance of the
Center’s goals

Establishing and maintaining internal communication, and
cooperation among Center investigators

Coordinating, managing, and integrating expertise and the studies
under the Scientific Project

Maintaining oversight of the Administrative Core and the
Educational Enrichment Program

Establishing and maintaining a website to advertise and highlight
the activities of the Educational Enrichment program

Creating mechanisms for internal monitoring, for selecting, and
replacing Center professional or technical personnel

Interdisciplinary
teams

A goal of the IR-BU program is to build teams that draw upon
a broad range of expertise to investigate lower urinary tract function/structure/development
and the underlying causes of lower urinary tract symptoms. Investigators within
and outside of urology are encouraged to interact in the broad field of lower
urinary tract biology to build the basic knowledge essential for establishing
conceptual/mechanistic models, tools, and resources necessary for developing
translational studies in lower urinary tract symptomatic disorders. Inclusion
of a urological clinician or physician scientist within the research team is
required to maintain awareness of the clinical relevance of the project to
lower urinary tract symptoms. In addition, teams are required to have active
involvement of established investigators with appropriately diverse expertise
although new investigators are allowed. Investigators who are part of an
existing O’Brien Urology Center may not submit an application.

Specific examples of team members might include:

Urologist with knowledge of urologic disorders and patient
populations to provide clinical relevance to the application

Neuroscientist, with knowledge of neurologic pathways and
neuro-imaging

The Scientific Research Project will be a single project and
will be overseen by a Program Director(s)/Principal Investigator(s) or multiple
Program Director(s)/Principal Investigator(s) (see Section IV. 2 Applications
with Multiple PD(s)/PI(s)). The Scientific Research Project will contribute to
our understanding of the etiology of lower urinary traction symptoms through
studies of the normal development, physiology, genetics and/or pathophysiology
of the lower urinary tract and associated organs and tissues. Because a goal of
the IR-BU Center is to build new teams, preliminary data are not required to
establish the collaborative interactions of the team members. The Scientific
Project may include human studies, and/or use mouse and other animal
experimental systems. Animal studies are appropriate for the study of normal
development, maturation, and physiology of the lower urinary tract system and
associated organs, and animal models are acceptable even though they might only
recapitulate aspects of urologic symptoms.

The strategy for establishing IR-BU teams is to provide the
intellectual infrastructure to foster projects that can mature into
comprehensive programs that take advantage of an understanding of the lower
urinary tract physiology/development/genetics and which can lead to the
determining the underlying etiology of lower urinary tract symptoms. Such a
comprehensive approach towards the study of lower urinary tract symptoms could,
for example, include the study of neural modulation, circadian rhythm,
epigentics and environmental factors in understanding social stress
incontinence; the study of diabetes/obesity, chronic inflammation, and
cholesterol in prostatic inflammation; or the study of inflammation,
macrophages, and fibrosis in BPH. Such comprehensive programs will lead the way
towards translational studies to prevent, diagnose, and manage lower urinary
tract symptoms.

To accelerate the ability to plan for future translational
studies, the research topics should encompass fundamental studies in lower
urinary tract biology (development/physiology/genetics) and dysfunction and
where appropriate include analysis of human samples from previous or ongoing
clinical studies/trials or human phenotyping studies.

Specific examples of research topics that are responsive to
this solicitation are listed below. Although cell culture studies are
permissible, they will need to be carefully justified. These are broad examples
meant only to provide illustration of potential directions, and not to be
restrictive.

Studies on the role of other pelvic organs (pelvic floor
musculature, gastrointestinal and or reproductive tract, etc.) in lower urinary
tract health and its contribution to lower urinary tract symptoms using in
vivo and ex vivo approaches

Studies involving early organ maturation and its maintenance
during normal aging in the development of lower urinary tract symptoms

Investigations involving age-dependent changes in function and
response to injury of the lower urinary tract

Studies on the role of distant organs (central and/or peripheral
nervous system) in the development, maintenance, or regression of normal urinary
function, and in the progression or expression of urinary tract voiding
symptoms

Studies on the genetics, development, and malformation of the
lower urinary tract

Studies on the age-dependent changes in function and response to
injury of the lower urinary tract

Studies on organ maturation and normal aging in the development
of lower urinary tract symptoms

Studies of the role of different cell types in heterogeneously
complex organs/tissues in initiating, maintaining, and regression of urinary
tract symptoms

Studies on the role of generalized processes such as
inflammation, adaptive or innate immunity, epigenetics, injury/regeneration,
etc. in promoting, and amplifying the progression, or regression of urologic
disorders.

Identification and extensive phenotyping of animal models for
altered central or peripheral nervous system function that might contribute to
lower urinary tract symptoms and extend the same phenotyping (where possible)
to relevant patient populations

To support the team building activities of the P20 centers
the IR-BU teams will meet bi-annually in Bethesda, initially to introduce the
IR-BU teams and subsequently to discuss progress on the establishment of
integrative research teams.

Section
II. Award Information

Funding Instrument

Grant

Application Types Allowed

New
Renewal

The OER
Glossary and the PHS398 Application Guide provide details on these application
types.

Funds Available and Anticipated Number of Awards

NIDDK intends to commit $1 million in FY 2012.

Award Budget

Applicants may request no more than $200,000 in direct
costs per year. The maximum budget for the Education Enrichment Program is
$25,000..

Award Project Period

The scope of the proposed project should determine the
project period. The maximum project period is two years.

NIH grants policies as
described in the NIH
Grants Policy Statement will apply
to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

Public/State Controlled Institutions of Higher Education

Private Institutions of Higher Education

The following types of Higher Education Institutions
are always encouraged to apply for NIH support as Public or Private
Institutions of Higher Education:

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
Foreign components, as defined in the NIH
Grants Policy Statement, are allowed.

Required Registrations

Applicant organizations must complete the following registrations
as described in the PHS398 Application Guide to be eligible to apply for or
receive an award. Applicants must have a valid Dun and Bradstreet Universal
Numbering System (DUNS) number in order to begin each of the following
registrations.

All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s))
must also work with their institutional officials to register with the eRA
Commons or ensure their existing eRA Commons account is affiliated with the eRA
Commons account of the applicant organization.

All registrations must be completed by the application due
date. Applicant organizations are strongly encouraged to start the registration
process at least4-6 weeks prior to the application due date.

Eligible Individuals (Program Director(s)/Principal Investigator(s))

Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director(s)/Principal
Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH support.

The Center Director must be an established investigator, but
need not have a record of accomplishment in urological research; however, the
inclusion of a urologic clinician or physician scientist in the IR-BU team is
required. It is expected that other IR-BU team members will have the diverse
expertise appropriate for the proposed studies in the Scientific Project. Therefore,
established investigators from diverse fields not traditionally involved in
urological studies are expected to be included and actively involved. New
investigators are also allowed but should not be substituted for established
investigators. Because not all relevant expertise may be represented at a
single institution, applicants are encouraged to establish teams through
collaborations with research groups outside their own institution.

The Center Director need not be the Administrative Core
Director. Investigators who are part of an existing O’Brien Urology Center are
not eligible to apply.

Applicant organizations may submit more than one application,
provided that each application is scientifically distinct.

NIH will not accept any application in response to this FOA
that is essentially the same as one currently pending initial peer review
unless the applicant withdraws the pending application. NIH will not accept any
application that is essentially the same as one already reviewed.

Section
IV. Application and Submission Information

1. Address to Request Application Package

Applicants are required to prepare applications according to
the current PHS 398 application forms in accordance with the PHS 398
Application Guide.

2. Content and
Form of Application Submission

It is critical that applicants follow the instructions in
the PHS398
Application Guide, except where instructed in this funding opportunity
announcement to do otherwise. Conformance to the requirements in the
Application Guide is required and strictly enforced. Applications that are out
of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

Although a letter of intent is not required, is not binding,
and does not enter into the review of a subsequent application, the information
that it contains allows IC staff to estimate the potential review workload and
plan the review.

By the date listed in Part 1. Overview
Information, prospective applicants are asked to submit a letter of intent
that includes the following information:

Applications must be prepared using the PHS 398 research
grant application forms and instructions for preparing a research grant
application. Submit a signed, typewritten original of the application,
including the checklist, and three signed photocopies in one package to:

Detailed Budgets (Initial and Entire Period) and
Budget Justifications for the Research Project and Administrative Core
including the Educational Enrichment Program)

Biographical Sketch – IR-BU center PD/PI

Other Biographic Sketches – Key Personnel, etc.

All Personnel Report

Checklist

Summary Description of the Proposed IR-BU Center
(limited to 6 pages including the subsections below)

Research team and the eligibility of the team (1-2 pages
recommended).

Scientific focus of the IR-BU Center.Administrative Core and the
Educational Enrichment Program (1-2 page recommended)

Research Plan

All instructions in the PHS398 Application Guide must be
followed, with the following additional instructions:

Resource Sharing Plan

Individuals are required to comply with the
instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model
Organisms, and Genome Wide Association Studies (GWAS)) as provided in the PHS398
Application Guide, with the following modification:

All applications, regardless of the amount of direct costs
requested for any one year, should address a Data Sharing Plan.

Appendix

Do not use the Appendix to circumvent page limits. Follow
all instructions for the Appendix (please note all format requirements) as
described in the PHS398 Application Guide.,

Foreign Institutions

Foreign (non-US) Institutions must follow policies described
in the NIH
Grants Policy Statement, and procedures for foreign institutions described
throughout the PHS398 Application Guide.

Applications must be received on or before the due dates in Part I. Overview Information. If an
application is received after that date, it will not be reviewed.

Upon receipt, applications will be evaluated for
completeness by the Center for Scientific Review and responsiveness by the
National Institutes of Diabetes and Digestive and Kidney Diseases (NIDDK), NIH.
Applications that are incomplete and/or nonresponsive will not be reviewed.

Applicants must budget for travel for at least three
investigators to attend bi-annual reverse site visit/progress meetings to be
held in Bethesda, Maryland. Funds for the Educational enrichment program are
limited to $25,000.

Supplemental Instructions:

Summary
of the Proposed IR-BU Center (limited to 6 pages)

ResearchTeam: Describe the research
team, expertise outside of the field of urology, and the role of team members
in addressing the research problem. Provide a statement for satisfying the
eligibility criteria bulleted in Section III.1.B for eligible individuals (1-2
pages recommended).

Scientific purpose of the IR-BU Center: Provide a
brief description of the research aims of the Scientific Research Project
followed by a explanation of how the Scientific Research Project integrates
organ-specific development, structure and function, and/or physiology and
pathophysiology studies with in vivo studies to understand the potential
interplay of urologic and non-urologic organs and tissues. Describe how will
this lead to an understanding of the development and persistence of lower
urinary tract symptoms.

Administrative
Core

Describe the administrative structure of the center
and its role in 1) the allocation and oversight of IR-BU Center resources, 2)
establishing and maintaining all collaborations and the Educational Enrichment
program, and 3) working with the institution and local regulatory bodies to
ensure that human subject or vertebrate animal research is in compliance with
appropriate regulations and guidelines governing animal use and studies
involving human subjects research. Describe the responsibilities of all
key personnel within the Administrative core.

Describe efforts to ensure the success of the team
building and the steps taken to ensure that the center will remain focused
throughout the course of the award. Provide a plan for ensuring the solvency of
the proposed team once an award has been made and for resolving conflicts
within the IR-BU Center. Specifically address administrative responsibilities
between the collaborating institutions, organizational components, faculty, and
staff.

The Administrative Director need not be the Center
Director.

Provide an official signed letter of understanding
establishing the collaboration between the institutions or organizational
components and document all significant inter-institutional commitments as
appropriate.

Educational
Enrichment Program

Describe how the Educational Enrichment program will
be organized and governed and how it will support or augment the development of
an interdisciplinary approach to the proposed studies. All IR-BU Centers are
expected to establish and maintain a website to advertise and highlight the
activities of the Educational Enrichment program.

Other
Requirements

The Center Director must be an established
investigator, but need not have a record of accomplishment in urological
research; however, the inclusion of a urologic clinician or physician scientist
in the IR-BU team is required. It is expected that other IR-BU teams will have
diverse expertise appropriate for the proposed studies in the Scientific
Project and therefore, new or established investigators from diverse fields not
traditionally involved in urological studies are expected to be included.
Because not all relevant expertise may be represented at a single institution,
applicants are encouraged to establish interdisciplinary teams through
collaborations with research groups outside their own institution.

Applicants must budget for travel for at least three
investigators to attend bi-annual reverse site visit/progress meetings to be
held in Bethesda, Maryland.

Post Submission Materials

Applicants are required to follow the instructions for
post-submission materials, as described in NOT-OD-10-115.

Section
V. Application Review Information

1. Criteria

Only the review criteria described below will be considered
in the review process. As part of the NIH mission,
all applications submitted to the NIH in support of biomedical and behavioral
research are evaluated for scientific and technical merit through the NIH peer
review system.

Overall Impact

Reviewers will provide an overall impact/priority score to
reflect their assessment of the likelihood for the Center to exert a sustained, powerful influence on the research field(s) involved, in consideration
of the following review criteria and additional review criteria (as applicable
for the Center proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in
the determination of scientific merit, and give a separate score for each. An
application does not need to be strong in all categories to be judged likely to
have major scientific impact. For example, a Center that by its nature is not innovative may be essential to advance a field.

Significance

Does the Center address an important problem or a
critical barrier to progress in the field? If the aims of the Center are achieved, how will scientific knowledge, technical capability, and/or clinical
practice be improved? How will successful completion of the aims change the
concepts, methods, technologies, treatments, services, or preventative
interventions that drive this field?

Does the ADMINISTRATIVE CORE enhance the
collaborative effort of bringing different fields of study together to
successfully carry out the proposed research? Does the Educational Enrichment
Program make significant contributions to the goals/specific aims of the IR-BU
Center? Does it foster integrative research approaches to understand the
underlying causes of benign lower urinary tract symptoms, or developmental,
functional, physiologic, or pathophysiological changes associated with lower
urinary tract symptoms?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other
researchers well suited to the Center? If Early Stage Investigators or New
Investigators, or in the early stages of independent careers, do they have
appropriate experience and training? If established, have they demonstrated an
ongoing record of accomplishments that have advanced their field(s)? If the
project is collaborative or multi-PD(s)/PI(s), do the investigators have
complementary and integrated expertise; are their leadership approach,
governance and organizational structure appropriate for the project?

Is the composition of the investigators appropriate
for building an interdisciplinary research team? What is the likelihood for
meaningful and long-term collaboration among the Center investigators? Does the
team include established investigators from non-urological fields and are they
making a substantial contribution to the project? Does the team have relevant
urology expertise, is a urologic clinician or physician scientist associated
with the project?

Are the scientific and administrative leadership
abilities of the proposed Center Director appropriate? Does the Center Director
have an appropriate time commitment for the effective management of the Center?
Is there evidence that the researchers and faculty of the partnering institutions
have worked closely together in the preparation of the application and will
continue to do so in meeting the proposed objectives?

Innovation

Does the application challenge and seek to shift
current research or clinical practice paradigms by utilizing novel theoretical
concepts, approaches or methodologies, instrumentation, or interventions? Are
the concepts, approaches or methodologies, instrumentation, or interventions
novel to one field of research or novel in a broad sense? Is a refinement, improvement,
or new application of theoretical concepts, approaches or methodologies,
instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the Center? Are potential problems, alternative strategies, and benchmarks for success presented?
If the project is in the early stages of development, will the strategy
establish feasibility and will particularly risky aspects be managed?

If the Center involves clinical research, are the plans for 1) protection of
human subjects from research risks, and 2) inclusion of minorities and members
of both sexes/genders, as well as the inclusion of children, justified in terms
of the scientific goals and research strategy proposed?

Will the Center foster new multidisciplinary interactions
and will these interactions generate the preliminary data necessary to
establish a well-integrated multidisciplinary research team that is capable of
generating new and innovative research grant applications?

If the project involves basic research using animal
models, is there a clear vision for how the studies will contribute to the
development of future translational studies?

Are the arrangements and organizational structure for
the ADMINISTRATIVE CORE adequately developed and appropriate for the aims of
the Scientific Project and the Educational Enrichment program? Does the
application describe how internal communication and cooperation among Center
investigators will be maintained? Are the arrangements for oversight and use of
funds for travel and the Educational Enrichment Program adequately described?
Are the resources and responsibilities appropriately distributed and justified
given the goal and objectives of the proposed IR-BU center? Does the applicant
describe an effective process for resolving conflicts between investigators?

Environment

Will the scientific environment in which the work
will be done contribute to the probability of success? Are the institutional
support, equipment and other physical resources available to the investigators
adequate for the project proposed? Will the project benefit from unique
features of the scientific environment, subject populations, or collaborative
arrangements?

Additional Review Criteria

As applicable for the Center proposed, reviewers will
evaluate the following additional items while determining scientific and
technical merit, and in providing an overall impact/priority score, but will
not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data
and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or
more of the six categories of research that are exempt under 45 CFR Part 46,
the committee will evaluate: 1) the justification for the exemption, 2) human
subjects involvement and characteristics, and 3) sources of materials. For
additional information on review of the Human Subjects section, please refer to
the Human
Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children

When the proposed Center involves clinical research, the committee will evaluate the proposed plans for inclusion
of minorities and members of both genders, as well as the inclusion of children.
For additional information on review of the Inclusion section, please refer to
the Human
Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live
vertebrate animals as part of the scientific assessment according to the
following five points: 1) proposed use of the animals, and species, strains,
ages, sex, and numbers to be used; 2) justifications for the use of animals and
for the appropriateness of the species and numbers proposed; 3) adequacy of
veterinary care; 4) procedures for limiting discomfort, distress, pain and
injury to that which is unavoidable in the conduct of scientifically sound
research including the use of analgesic, anesthetic, and tranquilizing drugs
and/or comfortable restraining devices; and 5) methods of euthanasia and reason
for selection if not consistent with the AVMA Guidelines on Euthanasia. For
additional information on review of the Vertebrate Animals section, please refer
to the Worksheet
for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures
proposed are potentially hazardous to research personnel and/or the
environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable.

Renewals

For Renewals, the committee will consider the
progress made in the last funding period.

Revisions

Not Applicable.

Additional Review Considerations

As applicable for the Center proposed, reviewers will
consider each of the following items, but will not give scores for these items,
and should not consider them in providing an overall impact/priority score.

Applications from Foreign Organizations

Reviewers will assess whether the project presents
special opportunities for furthering research programs through the use of
unusual talent, resources, populations, or environmental conditions that exist
in other countries and either are not readily available in the United States or
augment existing U.S. resources.

Select Agent Research

Reviewers will assess the information provided in
this section of the application, including 1) the Select Agent(s) to be used in
the proposed research, 2) the registration status of all entities where Select
Agent(s) will be used, 3) the procedures that will be used to monitor
possession use and transfer of Select Agent(s), and 4) plans for appropriate
biosafety, biocontainment, and security of the Select Agent(s).

Reviewers will consider whether the budget and the
requested period of support are fully justified and reasonable in relation to
the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical
merit by (an) appropriate Scientific Review Group(s) convened by National Institute of Diabetes and Digestive and Kidney Diseases in accordance with NIH peer
review policy and procedures, using the stated review
criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

May undergo a selection process in which only those applications
deemed to have the highest scientific and technical merit (generally the top
half of applications under review) will be discussed and assigned an overall
impact/priority score.

Applications will be assigned to the appropriate NIH Institute or Center and will compete for available funds with all
other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of
review by the NDDK Advisory Councill. The following will be considered in
making funding decisions:

Scientific and technical merit of the proposed project as
determined by scientific peer review.

Availability of funds.

Relevance of the proposed project to program priorities.

The extent to which the Center and the Administrative Core
activities are focused on integrating the biology of the lower urinary tract
function and dysfunction with advancing our knowledge of symptomatic urological
disorders.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the
PD(s)/PI(s) will be able to access his or her Summary Statement (written
critique) via the eRA Commons.

If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH
Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.

A final progress report, invention
statement, and the expenditure data portion of the Federal Financial Report are
required for closeout of an award, as described in the NIH
Grants Policy Statement..

The Federal Funding Accountability and Transparency Act of
2006 (Transparency Act), includes a requirement for awardees of Federal grants
to report information about first-tier subawards and executive compensation
under Federal assistance awards issued in FY2011 or later. All awardees of
applicable NIH grants and cooperative agreements are required to report to
the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH
Grants Policy Statementfor additional information on this
reporting requirement.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and
under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.